BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: No

    Recall: Z-1925-2025 · Reported June 18, 2025

    Enforcement

    Recall Number
    Z-1925-2025
    Event ID
    96761
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 18, 2025
    Initiation Date
    May 7, 2025
    Classification Date
    June 9, 2025
    Address
    2568 Bristol Cir, Oakville, N/A, Canada

    Description

    Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: No

    Reason

    Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.

    Code Info

    UDI-DI 00382830010825 Serial Numbers 001 through OBM00002H3613. Note earlier version serial numbers did not contain the sequence of "OBM"

    Distribution

    Worldwide distribution - US Nationwide including Puerto Rico (PR) and OUS (foreign) countries of: Italy (IT), Estonia (EE), Israel (IL), China (CN), Germany (DE), Saudi Arabia (SA), Switzerland (CH), Chile (CL), Colombia (CO), Netherlands (the) (NL), Japan (JP), United Kingdom of Great Britain and Northern Ireland(the) (GB), Russian Federation (the)(RU), Bolivia (Plurinational State of) (BO), Canada (CA), France (FR), Peru (PE), Guyana (GY), Mexico (MX), Belgium (BE), Thailand (TH), Paraguay (PY), Hong Kong (HK), United Arab Emirates (AE), Austria (AT), India (IN), Indonesia (ID), Kuwait (KW), Qatar (QA), Lithuania (LT), Denmark (DK), Myanmar (MM), Uruguay (UY), Tunisia (TN), Turkey (TR), Korea (the Republic of) (KR), Hungary (HU), Slovenia (SI), Argentina (AR), Norway (NO), Oman (OM), Poland (PL), Finland (FI), Ireland (IE), Australia (AU), Latvia (LV), Ecuador (EC), Singapore (SG), Spain (ES), Serbia (RS), South Africa (ZA), Romania (RO), Algeria (DZ), Portugal (PT), Dominican Republic (the) (DO), Lebanon (LB), Malaysia (MY), Costa Rica (CR), Viet Nam (VN), & Bahrain (BH).

    Quantity

    3069